ORYZON Receives $1.5 Million Grant from Alzheimer's Drug Discovery Foundation (ADDF)

Oryzon Genomics


ORYZON Receives $1.5 Million Grant from Alzheimer's Drug Discovery Foundation (ADDF)

Monday, May 20, 2019 9:50 AM
  • Proceeds to help fund ETHERAL-US Phase IIa examing vafidemstat in Alzheimer's disease
  • ADDF stake in the company represents 0.94 % of the common stock

MADRID, SPAIN and CAMBRIDGE, MA / ACCESSWIRE / May 20, 2019 / Oryzon Genomics (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the Board of Directors of the Alzheimer's Drug Discovery Foundation (ADDF) has approved a grant of $1.5 million to Oryzon Genomics S.A. to support the US-arm of Oryzon's ETHERAL Phase IIa clinical trial with vafidemstat in Alzheimer's disease (AD) patients.

ETHERAL (Epigenetic THERapy in ALzheimer's Disease) is already being conducted in 17 European hospitals across UK, France and Spain. It is designed as a randomised, double-blind, placebo-controlled, 3-arm, 26 weeks parallel-group study to evaluate the safety and tolerability of vafidemstat in patients with mild and moderate AD. The study incorporates a multiplicity of secondary endpoints measurements, including memory and behavior alterations. The study also monitors the variations of diverse CSF biomarkers including anti-inflammatory ones. The European arm of the study plans to enroll up to 125 patients, with more than 90 patients randomized up to date.

Recently, the company got FDA's IND approval to start the US arm of this study. This arm will involve multiple sites in the US and plans to enroll up to 30 patients, to complete a minimum of 150 patients on the aggregate.

Under the terms and conditions of the grant, the ADDF has received 367,250 ordinary shares of the Company, representing 0.94% of the capital.

Vafidemstat is a neuroactive molecule which is also being explored in other CNS and psychiatric conditions. The company recently reported first human efficacy data in reducing aggression in an open-label Phase IIa trial (REIMAGINE) in Borderline-personality Disorder (BPD) and Attention Deficit and Hyperactivity Disorder (ADHD) patients. Data on Autism Spectrum Disorder (ASD) and AD patients in the same study are expected later this year.

"Our continued investment in Oryzon reflects ADDF's long-standing support of studies that focus on drugs targeted toward multiple aging pathways" says Howard Fillit, M.D., founding executive director and chief science officer of the ADDF. "We are pleased to help advance the development of epigenetic therapies and vafidemstat as a novel therapeutic option for Alzheimer's disease."

Michael Ropacki, Oryzon's Vice-President of Clinical Development, has stated: "We appreciate the generosity of the ADDF, and their support to further vafidemstat's clinical development. The unique mechanism of action along with safety and efficacy data collected to-date suggest that vafidemstat may positively impact cognition, as well as the neuropsychiatric sequelae and behavioral problems of AD patients."

Carlos Buesa, CEO and Founder of Oryzon, said: "Support from the ADDF has been key over the years to advance the development of vafidemstat as a novel therapeutic option for Alzheimer's disease, and we are deeply grateful. The ADDF's decision to convert the grant into equity reflects its confidence in our project and the shared hope that this experimental drug may contribute to the cure of this terrible disease. With ETHERAL-US, the company is starting clinical operations in the US and we expect to expand the clinical trials with vafidemstat in the US to additional CNS indications soon".

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon's LSD1 program has rendered two compounds vafidemstat and iadademstat in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com.

About Vafidemstat

Vafidemstat (ORY-2001) is an oral, brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer's disease, to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Vafidemstat is in Phase IIa clinical studies in patients with Relapse-Remitting and Secondary Progressive MS (SATEEN), in patients with Mild to Moderate Alzheimer's disease (ETHERAL) and in aggressiveness in patients with different psychiatric or neurodegenerative disorders (REIMAGINE, a basket trial).

About the Alzheimer's Drug Discovery Foundation

Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation (ADDF) is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, the ADDF has awarded over $115 million to fund more than 590 Alzheimer's drug discovery programs and clinical trials in 18 countries. To learn more, please visit: http://www.alzdiscovery.org/.

FORWARD-LOOKING STATEMENTS

This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates" and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon's securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

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SOURCE: Oryzon Genomics


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